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Vibration on Patellofemoral Joint Pain After ACLR

Primary Purpose

Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture, Anterior Cruciate Ligament Tear

Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
WBV
PEMF
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anterior Cruciate Ligament Injuries focused on measuring ACLR, Patellofemoral joint, Whole Body vibration, Knee function

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age between 18 to 60
  2. Unilateral ACLR
  3. Persisting PFJ pain
  4. Isolated symptomatic site or pathology

Exclusion Criteria:

  1. Age > 60
  2. Bilateral ACLR
  3. Revision ACLR
  4. Any rheumatological diseases
  5. Previous contralateral knee injury
  6. Any knee osteoarthritis

Sites / Locations

  • The Chinese University of Hong KongRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Active Comparator

Arm Label

WBV + PEMF Group

Control Group

WBV only

Arm Description

Patients in "WBV + PEMF" and "WBV only" groups will be required to attend the WBV therapy session in Prince of Wales Hospital twice a week, for 8 weeks, fulfilling a total of 16 sessions. Patients in "WBV + PEMF" groups will receive PEMF after WBV session.

Subjects in control group will perform static squat, single leg squat and lunges without vibration.

Patients in "WBV + PEMF" and "WBV only" groups will be required to attend the WBV therapy session in Prince of Wales Hospital twice a week, for 8 weeks, fulfilling a total of 16 sessions. Patients in "WBV" groups will not receive PEMF after WBV session.

Outcomes

Primary Outcome Measures

Change of The Knee injury and Osteoarthritis Outcome Score Patellofemoral subscale (KOOS-PF)
The KOOS-PF was developed to evaluate individuals or samples of individuals who present with anterior knee pain/patellofemoral pain and/or patellofemoral OA. It contains 11 items with 3 subscale : Stiffness, Pain, Quality of life (QOL).

Secondary Outcome Measures

Isokinetic muscle strength
The subjects will be asked to test the muscle strength by using the isokinetic device (Biodex System 4; Biodex Medical Systems, Inc, Shirley, NY). Before testing, the subjects will be asked to have a 10-minute warm-up on a stationary bike at low intensity. By recommendation they will be asked to exert maximal concentric contraction of knee flexor and rt with the dynamometer at angular velocity of 60°/s for five times.
Muscle thickness
Muscle thickness of rectus femoris, vastus medialis, vastus lateralis and vastus intermedius will be assessed using ultrasound imaging. The ultrasound transducer will be placed at the muscle bellies to obtain an image of the cross-session of the muscle. The depth of the related muscle cross-session will be measured to represent the thickness of the muscle. Muscle thickness of rectus femoris, vastus medialis, vastus lateralis and vastus intermedius will be assessed using ultrasound imaging. The ultrasound transducer will be placed at the muscle bellies to obtain an image of the cross-session of the muscle. The depth of the related muscle cross-session will be measured to represent the thickness of the muscle.
The Numeric Pain Rating Scale (NPRS)
The Numeric Pain Rating Scale (NPRS): The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The 11-point numeric scale ranges from '0' representing "no pain" to '10' representing "the most severe pain imaginable". Scores range from 0-10 points, with higher scores indicating greater pain intensity.

Full Information

First Posted
March 22, 2022
Last Updated
August 28, 2023
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT05501210
Brief Title
Vibration on Patellofemoral Joint Pain After ACLR
Official Title
The Effect of Whole-Body Vibration on Patellofemoral Joint Pain After Anterior Cruciate Ligament Reconstruction
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
March 1, 2025 (Anticipated)
Study Completion Date
June 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Anterior cruciate ligament (ACL) injury is a prevailing problem among sports participants, especially in non-contact sports. Studies have reported that 70-84% of ACL injuries are non-contact in nature, and movements like changing in direction while running, cutting and pivoting on a planted foot have resulted in a majority of ACL injuries. Even after ACL reconstruction (ACLR) surgeries, study has reported a 30-50% prevalence of developing patellofemoral joint (PFJ) pain in 1-2 years post-operation. Whole body vibration (WBV) therapy has been gaining attention as an effective method of training in recent years. It has been proved to have a positive effect on improving muscle strength, muscle activities, muscle power and loading during drop jump. Though duration of WBV may differ according to the effect of interest, several studies have had positive results with a 8 week WBV therapy in increasing muscle strength, proprioception, and post-ACLR knee functions. Further investigation on the underlying mechanism and possible application are to be continued to explore more possibilities with the WBV therapy.
Detailed Description
Anterior cruciate ligament (ACL) injury is a prevailing problem among sports participants, especially in non-contact sports. Studies have reported that 70-84% of ACL injuries are non-contact in nature, and movements like changing in direction while running, cutting and pivoting on a planted foot have resulted in a majority of ACL injuries. The influence of such injury can often be lifelong as it increases the patient's risk of developing degenerative musculoskeletal problems like osteoarthritis, and eventually affects the patient's quality of life. Even after ACL reconstruction (ACLR) surgeries, study has reported a 30-50% prevalence of developing patellofemoral joint (PFJ) pain in 1-2 years post-operation. The prevalence of patients developing PFJ osteoarthritis ranges from 14.8-26.5% for post-operation 2-5 years, and the percentage is even higher after more than 6 years post-operation. Symptoms of PFJ osteoarthritis include swelling, notably reduced quadriceps strength, and pain on PFJ compression. Though the mechanism of how ACLR contributes to the development of PFJ osteoarthritis is not completely clear yet, inflammation and damage to PFJ articular cartilage and alteration of vastus medialis function, which is common after ACLR, might play a role in the development of PFJ osteoarthritis. A more than 30% decrease in quadriceps muscles strength had been reported by previous study. Decrease in size of rectus femoris, vastus medialis and vastus lateralis had also been observed. Though there was no significant difference in the vastus medialis/vastus lateralis, the decrease in strength and size of the quadricep muscles could possibly affect the stability of PFJ, increasing the chance of developing PFJ osteoarthritis. Whole body vibration (WBV) therapy has been gaining attention as an effective method of training in recent years. More and more rehabilitation facilities have equipped the WBV machine and make this therapy more easily accessible. It has been proved to have a positive effect on improving muscle strength, muscle activities, muscle power and loading during drop jump. It has also shown effectiveness in decreasing osteoarthritic knee pain and enhancing knee function in chronic elderly knee osteoarthritis. Though the exact mechanism of the therapy is not yet very clear, it is believed that it is related to the "tonic vibration reflex". Skeletal muscles undergo small changes in muscle length during the vibration generated by the machine. It elicits the "tonic vibration reflex", activates muscle spindles and mediated neural signals. Another possible mechanism is that the vibration provides cortical stimulation and increases the corticomotor excitability. Both of them train the neuromuscular system to response faster, achieving the above-mentioned benefits. There are different types of WBV machines, providing vertical, horizontal or pivoting vibration, and the amplitude and frequency of the vibration can be adjusted on the machine. Many studies have been conducted using different duration, amplitude and frequency of vibration. A "standard protocol" for WBV therapy is yet to be developed. Though duration of WBV may differ according to the effect of interest, several studies have had positive results with a 8 week WBV therapy in increasing muscle strength, proprioception, and post-ACLR knee functions. Further investigation on the underlying mechanism and possible application are to be continued to explore more possibilities with the WBV therapy. Conservative and effective approaches for relieving pain are needed for knee osteoarthritis patients and, among these, pulsed electromagnetic fields (PEMF) are emerging with promising results. In vitro studies have demonstrated that PEMF therapy is effective in reducing chondrocyte apoptosis and MMP-13 expression of knee cartilage in ovariectomized rats and in favourably affecting cartilage homeostasis. PEMF was evaluated for function, a significant improvement was observed 8 weeks after initiation of treatment, and no significant association was found between the use of PEMF and the occurrence of adverse events.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture, Anterior Cruciate Ligament Tear, Patellofemoral Pain
Keywords
ACLR, Patellofemoral joint, Whole Body vibration, Knee function

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be assigned into either vibration or control groups.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
WBV + PEMF Group
Arm Type
Experimental
Arm Description
Patients in "WBV + PEMF" and "WBV only" groups will be required to attend the WBV therapy session in Prince of Wales Hospital twice a week, for 8 weeks, fulfilling a total of 16 sessions. Patients in "WBV + PEMF" groups will receive PEMF after WBV session.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Subjects in control group will perform static squat, single leg squat and lunges without vibration.
Arm Title
WBV only
Arm Type
Active Comparator
Arm Description
Patients in "WBV + PEMF" and "WBV only" groups will be required to attend the WBV therapy session in Prince of Wales Hospital twice a week, for 8 weeks, fulfilling a total of 16 sessions. Patients in "WBV" groups will not receive PEMF after WBV session.
Intervention Type
Device
Intervention Name(s)
WBV
Intervention Description
Whole body vibration (WBV) therapy
Intervention Type
Device
Intervention Name(s)
PEMF
Intervention Description
Pulsed electromagnetic fields (PEMF)
Primary Outcome Measure Information:
Title
Change of The Knee injury and Osteoarthritis Outcome Score Patellofemoral subscale (KOOS-PF)
Description
The KOOS-PF was developed to evaluate individuals or samples of individuals who present with anterior knee pain/patellofemoral pain and/or patellofemoral OA. It contains 11 items with 3 subscale : Stiffness, Pain, Quality of life (QOL).
Time Frame
pre intervention and 8 weeks post intervention
Secondary Outcome Measure Information:
Title
Isokinetic muscle strength
Description
The subjects will be asked to test the muscle strength by using the isokinetic device (Biodex System 4; Biodex Medical Systems, Inc, Shirley, NY). Before testing, the subjects will be asked to have a 10-minute warm-up on a stationary bike at low intensity. By recommendation they will be asked to exert maximal concentric contraction of knee flexor and rt with the dynamometer at angular velocity of 60°/s for five times.
Time Frame
pre intervention and 8 weeks post intervention
Title
Muscle thickness
Description
Muscle thickness of rectus femoris, vastus medialis, vastus lateralis and vastus intermedius will be assessed using ultrasound imaging. The ultrasound transducer will be placed at the muscle bellies to obtain an image of the cross-session of the muscle. The depth of the related muscle cross-session will be measured to represent the thickness of the muscle. Muscle thickness of rectus femoris, vastus medialis, vastus lateralis and vastus intermedius will be assessed using ultrasound imaging. The ultrasound transducer will be placed at the muscle bellies to obtain an image of the cross-session of the muscle. The depth of the related muscle cross-session will be measured to represent the thickness of the muscle.
Time Frame
pre intervention and 8 weeks post intervention
Title
The Numeric Pain Rating Scale (NPRS)
Description
The Numeric Pain Rating Scale (NPRS): The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The 11-point numeric scale ranges from '0' representing "no pain" to '10' representing "the most severe pain imaginable". Scores range from 0-10 points, with higher scores indicating greater pain intensity.
Time Frame
pre intervention and 8 weeks post intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age between 18 to 60 Unilateral ACLR Persisting PFJ pain Isolated symptomatic site or pathology Exclusion Criteria: Age > 60 Bilateral ACLR Revision ACLR Any rheumatological diseases Previous contralateral knee injury Any knee osteoarthritis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Tim-Yun Ong, Prof.
Phone
85235052723
Email
michael.ong@cuhk.edu.hk
Facility Information:
Facility Name
The Chinese University of Hong Kong
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Tim-Yun Ong
Phone
26364171
Email
michael.ong@cuhk.edu.hk

12. IPD Sharing Statement

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Vibration on Patellofemoral Joint Pain After ACLR

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